Joy A. Cavagnaro, PhD, DABT, RAC is the President of Access BIO, Boyce, VA, a consultancy specializing in science-based regulatory strategies and preclinical product development services to facilitate biomedical research and emerging technologies. Specific product areas of expertise include vaccines, cellular and gene therapies, animal-based and plant-based biotherapeutics, biotechnology-derived and tissue engineered products.
Dr. Cavagnaro received her Ph.D. in Biochemistry at the UNC Chapel Hill followed by postgraduate work at Duke and Boston University Medical Centers. She has over 25 years experience in biotech spanning academia, the CRO and biotech industries and government. Prior to establishing Access BIO, Dr. Cavagnaro was Vice President of Regulatory Affairs at Human Genome Sciences, Inc. Dr. Cavagnaro enjoyed a career in government at the FDA Center for Biologics Evaluation and Research before rejoining industry.
During her tenure she was appointed to the Senior Biomedical Research Service, served as FDA's topic lead for safety for the ICH initiative for seven years and rapporteur for the ICH S6 Guidance on Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals. She also chaired the working groups responsible for FDA's 1996 Comparability Guidance Document and 1995 Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals. Her last official FDA duty was to Chair the Annual FDA Science Forum on Regulatory Sciences, December 1997. Prior to joining FDA Dr. Cavagnaro was principal study director for biotechnology products at Covance (formerly Hazleton Labs). Dr. Cavagnaro is Past Chair of the Regulatory Affairs Professional Society, National Capital Area Chapter of the Society of Toxicology and Immediate Past Chair and Founder of BioSafe, a focused expert science committee within BIO which identifies key scientific and regulatory issues and developments related to the preclinical safety evaluation of biopharmaceutical products. Dr. Cavagnaro is current North American Chair of DIA's Biotech SIAC and is co-chair of Chesapeake Research Review's Independent IRB. She also serves on the Steering Committee for the NIH National Gene Vector Laboratory and is a member of the Clinical and Regulatory Affairs Committee of the American Society of Gene Therapy. Dr. Cavagnaro was the US BIO representative to the ABPI/BIA Early Stage Clinical Trials Taskforce.

Richard M. Lewis, Ph.D. is the CEO of Access BIO, L.C., a pharmaceutical consulting company located in Northern Virginia, USA, which focuses on regulatory strategies for the development of biological products and devices. Specific product areas of expertise include blood-derived products, vaccines, cellular and gene therapies, biotechnology-derived and tissue engineered products Prior to joining Access BIO in 2004, Dr. Lewis was the Deputy Director of the Office of Blood Research and Review (OBRR), CBER. Dr. Lewis joined the FDA as a member of the laboratory research and review group in the Division of Hematology in 1989. His research involved coagulation inhibitors and review included many plasma derivatives. He became Chief of the Hematologic Products Branch in the Division of Blood Applications OBRR in 1995. There he was responsible for the project management and regulatory review of hematologic products as well as the clinical trial review for OBRR IND submissions. Prior to joining the FDA, Dr. Lewis was at the United States Army Research Institute of Infectious Diseases where he directed laboratory research on hemorrhagic dysfunction related to viral disease. As a graduate student at the University of North Carolina, where he earned his Ph.D., and as a post-doctoral fellow at Tufts University, he worked on the biochemistry and molecular conformation of vitamin K-dependent coagulation proteins.